Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hik
Summary
The FDA issued a Class III for Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in by Hikma Injectables USA Inc. Reason: Labeling: Wrong Barcode.
Details
Source
Drug Recall
External ID
D-0480-2024
Action Date
2024-05-08
Status
Completed
Category
drug
Product Description
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Lot/Code Info: Lot #: CH0324001, Exp. Date 3/4/2025
Quantity Affected: 1,895 bags
Reason for Recall
Labeling: Wrong Barcode
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-30
Company
Dayton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 86 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Hikma Injectables USA Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Injectables USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Injectables USA Inc have FDA actions?
Hikma Injectables USA Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0480-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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